Chemotherapy of disseminated melanoma with bleomycin, vincristine, CCNU, and DTIC (BOLD regimen)

Abstract

Fifty-one patients with advanced malignant melanoma (M.D. Anderson Stage IV) were treated with a four-drug regimen known as the BOLD protocol. In brief, the 5-day treatment consisted of bleomycin, 7.5 U subcutaneously (SC) on the first course and 15 U on days 1 and 4; vincristine, 1 mg/m2 intravenously (IV) on days 1 and 5; CCNU, 80 mg/m2 orally on day 1; and DTIC, 200 mg/m2 IV on days 1 through 5. The entire cycle was repeated every 4 to 6 weeks. Sixteen patients had been previously treated for localized disease with surgery and bacillus Calmette-Guerin (BCG) immunotherapy before relapsing with advanced disease. The BCG therapy was continued in these patients during the between-cycle periods. There were only two short-lived partial responses (4%). The median survival time for all patients was 17.0 weeks and for those who completed at least two chemotherapy cycles (44 patients) was 17.3 weeks. Four candidate prognostic factors were analyzed with respect to the overall survival of all patients: age, sex, site of metastatic spread, and use of concurrent BCG therapy. None played a significant explanatory role either in univariate or multivariate analyses. These unfavorable results preclude the recommendation of this multiagent therapy as a substitute for single-drug (DTIC) regimens aimed at the palliation of advanced, disseminated malignant melanoma.